Skelaxin
- Product NDC
- 68788-0881
- 11-digit product format
- 687880881
- Labeler code
- 68788
- Product ID
- 68788-0881_b22d36c8-d346-4853-a73e-fb653231ed3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- NDA013217
- Marketing category
- NDA
- Marketing start
- 2003-01-30
- Marketing end
- 0000-00-00
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe1c2a6-5488-f909-3872-734054eb745a | Product name | 5 | 20181231 |
| 776ba7f6-e5b0-442b-bd42-1fdfdfd821a4 | Product name | 1 | 20150615 |
| 68c52498-c9cb-48ab-a792-a4876149361e | Product name | 1 | 20150409 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-0881-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cc47-8e05-e053-dbdaa90a074a | d8684144-6c2d-4664-943a-2d3d2b46b1fc |
| 68788-0881-3 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cc47-8e05-e053-dbdaa90a074a | d8684144-6c2d-4664-943a-2d3d2b46b1fc |
| 68788-0881-6 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cc47-8e05-e053-dbdaa90a074a | d8684144-6c2d-4664-943a-2d3d2b46b1fc |
| 68788-0881-9 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cc47-8e05-e053-dbdaa90a074a | d8684144-6c2d-4664-943a-2d3d2b46b1fc |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-0881-1 | Skelaxin | 120 in 1 BOTTLE | TABLET | 120 | 5 | |
| 68788-0881-3 | Skelaxin | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 68788-0881-6 | Skelaxin | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 68788-0881-9 | Skelaxin | 90 in 1 BOTTLE | TABLET | 90 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 | |
| CALCIUM | INACTIVE INGREDIENT | SY7Q814VUP | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-0881 | SKELAXIN (METAXALONE) TABLET [PREFERRED PHARMACEUTICALS, INC] | 5 | Legacy NDC, 4 package rows | 20110510_d8684144-6c2d-4664-943a-2d3d2b46b1fc.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351254 | metaxalone 800 MG Oral Tablet | PSN | d8684144-6c2d-4664-943a-2d3d2b46b1fc | 5 |
| 352277 | Skelaxin 800 MG Oral Tablet | PSN | d8684144-6c2d-4664-943a-2d3d2b46b1fc | 5 |
| 352277 | metaxalone 800 MG Oral Tablet [Skelaxin] | SBD | d8684144-6c2d-4664-943a-2d3d2b46b1fc | 5 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | d8684144-6c2d-4664-943a-2d3d2b46b1fc | 5 |
| 352277 | Skelaxin 800 MG Oral Tablet | SY | d8684144-6c2d-4664-943a-2d3d2b46b1fc | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68788-0881-1 | 68788088101 | 120 in 1 BOTTLE | Historical |
| 68788-0881-3 | 68788088103 | 30 in 1 BOTTLE | Historical |
| 68788-0881-6 | 68788088106 | 60 in 1 BOTTLE | Historical |
| 68788-0881-9 | 68788088109 | 90 in 1 BOTTLE | Historical |